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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201201000348300 Date registered: 2012/01/23
TRIAL DESCRIPTION
Public title The value of ketamine when added to bupivacine in cervical plexus block in thyroid surgery
Official scientific title The dual benefit of preemptive ketamine in bilateral superficial cervical plexus block to reduce postoperative pain, wound hyperalgesia and allodynia after thyroid surgery.
Brief summary describing the background
and objectives of the trial
Sixty 18 to 60 years old undergoing thyroid surgery were simply randomized into two equal groups, thirty patients received bilateral superficial BSCPB using 9ml bupivacaine 0.25% solution mixed with 1ml normal saline (Bupivacaine group) and thirty patients received BSCPB using 9ml 0.25% bupivacaine solution mixed with 1ml ketamine 50mg/ml (Ketamine group).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2012-02-01
Actual trial start date
Anticipated date of last follow up 2012-12-31
Actual date of last follow up
Anticipated target sample size (number of participants) 60   
Actual target sample size (number of participants)   
Recruitment status Not yet recruiting
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program sealed envelopes Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control group Bupivacaine Group 2.5mg once bilaterial superficial BSCPB using 9ml bupivacaine .25% solution mixed with 1ml normal saline 30 Active
Experimental group Ketamine Group 50mg once bilaterial superficial BSCPB using 9ml bupivacaine .25% solution mixed with 1ml ketamine at 50mg/ml 30

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
adult patients undergoing elective thyroid surgery infection 18 Years 60 Years Both

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2011/11/15 Ethical Committee of Faculty of Medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
Elguish St Tanta Egypt

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain 24 hours postoperatively
Primary Outcome Analgesic requirement 24 hours post operatively
Primary Outcome Chronic pain 6 months

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university Elguish Street Tanta Egypt

FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine, Tanta University Elguish Street Tanta Egypt

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine, Tanta University Elguish Street Tanta Egypt University

COLLABORATORS
Name Street address City Postal code Country
Walid Ahmed Moustafa Elgiesh St Tanta Egypt

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403328002
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem St Tanta Egypt Assistant professor of anaesthesia
Role Name Email Phone Fax
Public Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403328002
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem St Tanta Egypt Assistant professor of anaesthesia
Role Name Email Phone Fax
Scientific Enquiries Dr Ayman Yousef ayman.yousef@rocketmail.com 00201003497767 0020403328002
Street address City Postal code Country Position / Affiliation
17 Elemam Moslem St Tanta Egypt Assistant professor of anaesthesia